NEAT (Novel endovascular access trial) data presented at the Vascular Interventional Advances (VIVA) 2016 meeting (18–22 September, Las Vegas, USA) suggest that endovascular arteriovenous fistula creation using everlinQ technology (TVA Medical) is associated with almost six-fold fewer post-creation interventions and may be approximately US$11,000 cheaper than surgical fistula creation.
Over the past two decades, there has been more than a 150% increase in dialysis treatment worldwide. Currently, 20-60% of traditional surgically created fistulae are not suitable for dialysis and require an average of two to three interventions to facilitate and/or maintain use, explained Charmaine Lok, University of Toronto, Toronto, Canada. Mean maturation time ranges from four to nine months and occlusions (thrombosis) rates have been reported as high as 17–25%, while the cost of the first year of arteriovenous fistulae intervention ranges from US$15–20,000. This, Lok said, represents a “significant unmet need, and there needs to be another option for fistula creation and maintenance”.
At the 2015 VIVA meeting, Lok presented the endovascular everlinQ system as a potential alternative to traditional fistula creation. The system uses an arterial and a venous catheter, aligned using magnets, with the fistula created by a radiofrequency electrode.
The 12-month prospective, non-randomised multicentre study—NEAT—enrolled 60 patients in Canada, Australia and New Zealand to evaluate the safety and efficacy of everlinQ to create arteriovenous fistulae with a primary efficacy endpoint of three-month fistulae maturation (defined as the proportion free of stenosis or thrombosis with a brachial artery blood flow ≥500mL/min and vein diameter ≥4mm). Patency and post-creation intervention rates were also included as additional study endpoints.
Lok and colleagues also used a cohort of Medicare patients treated with traditional surgical arteriovenous fistulae creation to see how their post creation intervention rates and costs compared with everlinQ endovascular creation. Propensity score matching was used to create the surgical comparator, and balance was achieved with no significant differences between the two groups for all baseline patient characteristics.
By three-month follow-up, over 90% of endovascular fistulae were physiologically mature. Technical success was 98%, procedure/device-related severe adverse event was <10% and the mean blood flow was >900mL/mm. The intervention rate by patient year was almost six times higher for traditional, surgically created fistulae compared with endovascular fistulae. This difference in intervention rates was reflected in associated costs, with endovascular treatment found to be approximately US$11,000 cheaper than traditional surgical fistulae creation—approximately US$1,800 Vs. US$13,000.
“NEAT demonstrates that the everlinQ technology is a promising technology for facilitating arteriovenous fistulae creation for both pre-dialysis and dialysis chronic kidney disease patients,” Lok told the VIVA audience.